Divya

Good Laboratory Practices (GLP) Trainer in Ghaziabad

Good Laboratory Practices (GLP)
QMS
Quality by Design

Location: Ghaziabad, India
Trainer Since: May, 2011

Trainer profile

Good Laboratory Practices (GLP) Trainer in Ghaziabad

About Divya

Divya is an exceptional professional who plays a vital role in the Quality Control department as the group in charge. With a wealth of experience and expertise, Divya is responsible for overseeing and ensuring timely, adequate, and accurate analysis of samples. His contributions as the QC head extend beyond analysis, encompassing a wide range of responsibilities such as strategic planning, purchasing laboratory requirements, and coordinating various aspects of the department.

His profound knowledge and skills in areas such as GLP (Good Laboratory Practices), QMS (Quality Management Systems), CSV (Computer Systems Validation), and the analysis of Stability, Raw Material (RM), and Finished Goods (FG) samples are invaluable. His meticulous approach ensures that the highest quality standards are upheld throughout the analysis process. Divya's unwavering commitment to maintaining quality control not only benefits the organization but also safeguards the satisfaction and trust of customers.

Divya is a Corporate Trainer For

Good Laboratory Practices (GLP)

Training Since:May, 2011

QMS

Training Since:May, 2011

Quality by Design

Training Since:July, 2012

Work Experience

Deputy General Manager Quality Control
Life Sciences · October, 2022 - present
Roles & Responsibilities
- Led and manage the day-to-day activities of the Quality Control department, ensuring compliance with industry standards, regulations, and company policies related to industrial research and toxicology
- Collaborate with cross-functional teams to develop and implement comprehensive quality control strategies, ensuring effective and efficient processes for testing, analyzing, and evaluating industrial research and toxicology data
- Stay up-to-date with relevant regulatory requirements and industry best practices, ensuring that the quality control processes adhere to all necessary guidelines and standards within industrial research and toxicology
- Establish and maintain quality assurance protocols to monitor and evaluate the accuracy, precision, and reliability of data generated through various industrial research and toxicology studies
- Supervise and mentor the Quality Control team, providing guidance on technical matters, conducting performance evaluations, and organizing training programs to enhance the team's skills and knowledge in industrial research and toxicology
- Identify areas for process improvement within the quality control function, implement corrective and preventive actions, and drive initiatives to enhance overall efficiency, productivity, and data integrity in industrial research and toxicology operations
Senior Manager Control
Life Sciences · January, 2022 - September, 2022
Roles & Responsibilities
- Oversaw and managed the day-to-day operations of the laboratory, ensuring the efficient and smooth functioning of all testing activities
- Implemented and enforced stringent quality control measures to ensure the accuracy and reliability of test results, adhering to industry standards and regulations
- Led a team of laboratory technicians and analysts, providing guidance, training, and performance evaluations to maintain a highly skilled and motivated workforce
- Collaborated with the research and development department to design and optimize testing protocols and methodologies, staying at the forefront of technological advancements
- Acted as the primary liaison between the laboratory and external partners, clients, and regulatory authorities, facilitating communication and addressing inquiries or concerns
- Conducted regular audits and risk assessments to identify potential areas for improvement and implemented corrective actions to enhance safety protocols and minimize operational risks
Assistant Manager Quality Control
Pharmaceutical · August, 2016 - December, 2021
Roles & Responsibilities
- Work in good coordination with the peers, especially in areas of resource sharing and when working with teams and also to ensure the necessary assistance is provided to them for their timely, adequate and accurate completion of the assigned work
- Improve staff performance through training, attention to detail and empathetic problem-solving methods
- Integrity, accuracy and adequacy of the analysis performed in the laboratory
- Assist with the preparation of staff assessments
- Maintaining of Working Standards, Reference Standards, Column Management, Instrument Calibration and Preventive Maintenance, Installation Qualification of Instrument, Compliance group & QMS group (Handling of Out of Specification, Out of Trend, Investigations and Deviations)
- Working in Quality Control department as group in charge to ensure timely, adequate and accurate analysis of samples
- Interaction on a continuous basis to understand the assigned job and feed back to superior on its status
- Work on Cleaning Validation, Method validation, Checking and Review of Finished Products Documents of SOP’s, In process Products and Semi Finished Goods testing on Enzymatic products like as Panceratin, Lipase, Amylase
- Implemented ideas and best practices whilst controlling costs in line with company procedures, without compromising standards and quality
- Handling of various QMS software’s
- Approximately 80 Nos. of Quality Control Staff handling experience
Executive Exhibit Stability
Pharmaceutical · August, 2011 - July, 2016
Roles & Responsibilities
- Conducted thorough stability testing and analysis of pharmaceutical products manufactured to assess their shelf-life and quality over time
- Oversaw and managed stability studies, ensuring compliance with regulatory guidelines and industry standards, such as ICH (International Council for Harmonisation) guidelines
- Collaborated with cross-functional teams, including Research & Development, Quality Control, and Regulatory Affairs, to gather relevant data and evaluate product stability profiles
- Provided expertise in stability-related matters during product development, ensuring appropriate stability protocols were implemented and followed
- Prepared and reviewed stability reports and documentation for submission to regulatory authorities as part of the drug approval process, demonstrating product efficacy and safety over time
- Proactively identified and addressed potential stability issues, working closely with manufacturing and quality teams to implement corrective actions and improve product stability and overall quality
Executive Quality Control
Pharmaceutical · July, 2005 - July, 2011
Roles & Responsibilities
- Performed thorough analysis and inspection of pharmaceutical products during manufacturing to ensure compliance with established quality standards and regulatory requirements
- Conducted regular audits and reviews of manufacturing operations to identify potential deviations or non-compliance issues, taking necessary corrective actions as needed
- Collaborated with cross-functional teams, including production and quality assurance, to implement and maintain effective quality control procedures and continuous improvement initiatives
- Coordinated and oversaw the calibration and maintenance of laboratory equipment and testing instruments to ensure accurate and reliable test results
- Participated in investigating customer complaints and product recalls, conducting root cause analysis, and contributing to developing preventive measures to mitigate future quality-related issues
- Prepared and maintained comprehensive documentation and reports on quality control activities, test results, and compliance status to support regulatory submissions and internal quality assessments